The purpose of this study is to determine whether the gentamicin-collagen sponge when
combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and
effective in treating moderately infected skin ulcers compared to treatment only with
standard daily wound care and an oral antibiotic (levofloxacin).
Infected skin ulcers with diabetes can be very debilitating because they are difficult to
heal. Diabetic ulcers are responsible for frequent health care visits, and are a major
predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense
pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to
the foot. Early aggressive treatment is necessary to treat infection and ultimately prevent
the need for amputation.
Gentamicin is an antibiotic that is effective in treating certain kinds of infection.
Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a
thin flat sponge made out of collagen that comes from cow tendons and containing gentamicin.
When applied to an open ulcer, the collagen breaks down and the gentamicin is released into
the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin
in the open infected ulcer may help treat the infection.
In this study, all subjects will be given the necessary supplies and taught how to take care
their foot ulcer. All subjects will also receive oral an antibiotic (levofloxacin).
Additionally, subjects who are randomly assigned to receive the gentamicin-collagen sponge
will place a gentamicin-collagen sponge on their ulcer during daily wound care.
- Is a man or woman aged ≥ 18 and ≤ 80 years.
- Has diabetes mellitus, according to the American Diabetes Association criteria.
- Has a single infected skin ulcer below the knee, defined as "moderate" by the
Infectious Disease Society of America (IDSA) Guidelines for whom, in the
Investigator's opinion, intravenous (IV) or oral antimicrobial therapy is appropriate
- Has had an x ray of the infected area within the 2 days immediately preceding or at
Visit 1 (Baseline/Randomization) to document the presence or absence of
osteomyelitis. Patients with osteomyelitis must receive appropriate surgical
intervention to remove all necrotic and infected bone and otherwise meet enrollment
criteria before being enrolled in the study.
- Meets certain minimal laboratory criteria
- Has an ankle brachial index (ABI) > or = 0.7 and ≤ 1.3. (Note: Patients with ABI
< 0.7 or > 1.3 may be included if they have either a transcutaneous oxygen
pressure or a toe pressure > or = 40 mm Hg on limb with ulcer.)
- If female, is nonpregnant (negative pregnancy test results at the
Baseline/Randomization Visit) and nonlactating.
- If female, is either not of childbearing potential (defined as postmenopausal for ≥
1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or
hysterectomy]) or practicing a medically acceptable methods of birth control and
agrees to continue with the regimen throughout the study
- Willing to return to the study facility for the Final Study Visit.
- Must be able to fluently speak and understand English and be able to provide
meaningful written informed consent for the study.
- Has a known history of hypersensitivity to gentamicin (or other systemic
aminoglycosides) or levofloxacin or drugs in the same class, or any of the test
article or reference product components.
- Has a known hypersensitivity to bovine collagen.
- Has any uncontrolled illnesses that, in the opinion of the Investigator, would
interfere with interpreting the results of the study.
- Has a target ulcer with a wound size > 10 × 10 cm.
- Has gangrenous tissue of the affected limb that cannot be removed with a single
- Has wound known to contain isolates resistant to levofloxacin.
- Has a wound associated with prosthetic material or device.
- Received any topical or systemic antimicrobial therapy within the 2 weeks prior to
study entry (Visit 1 [Day 1]).
- If severely immunocompromised, may be excluded at the discretion of the Investigator.
- Has a history of alcohol or substance abuse in the past 12 months.
- Has serum creatinine > 3 mg/dL, is undergoing dialysis (renal or peritoneal) or has
a history of kidney transplant.
- Has a history of myasthenia gravis or other neurological condition where gentamicin
use is contraindicated as determined by the Investigator.
- Has a history of epilepsy
- Has a history of tendon disorders related to fluoroquinolone administration